RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER by ACCELETRONICS DIGITAL IMAGING, LLC.

Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.

Device Description

The RAD II KV Imaging device is mounted directly to the head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.

AI/ML Overview

This 510(k) summary for the Acceletronics RAD II Simulator & RAD II KV Imager focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving performance against those criteria.

Therefore, many of the requested sections regarding specific acceptance criteria, detailed study results, sample sizes, expert qualifications, and ground truth establishment are not provided in this document. The document primarily relies on comparing the technological characteristics and intended use of the RAD II devices to previously cleared devices.

Here's a breakdown of the information available and what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the RAD II Simulator & RAD II KV Imager. Instead, it claims substantial equivalence based on:

Technological Characteristics: As detailed in Exhibit C-4 (page 2), comparing components like X-ray tube, generator, imager type (digital vs. film), and software with predicate devices.
Intended Use: For verification of patient position and treatment fields in radiation therapy.

Example Comparison (from Exhibit C-4, not formal acceptance criteria):

Feature	Predicate Devices (Varian OBI, Elekta Synergy)	RAD II KV Imager (Proposed Device)
Imager Type	Amorphous Silicon Imaging Panel	NAOMI Imager by RF SYSTEMS LAB (Digital)
X-Ray Tube	Qty. 1 Rad-60, Varian 50-150kVp	Qty. 1 or 2 Rad-60, Varian 50-150kVp
Patient Positioning Software	Proprietary Software	Theraview Software by Cablon
Application	Therapy attached diagnostic device for patient positioning verification.	Therapy attached diagnostic device for patient positioning verification.

2. Sample size used for the test set and the data provenance

Not provided. The submission focuses on substantial equivalence based on technical specifications and intended use, not on specific clinical or performance testing data with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided. There is no mention of a test set with established ground truth or expert involvement in such a process within this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided. Due to the absence of a described test set and ground truth establishment, no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This submission is for a device that aids in patient positioning and image acquisition in radiation therapy. It is not an AI-assisted diagnostic tool for human readers in a way that an MRMC study on reader improvement would typically be conducted. Therefore, no information on human reader improvement with/without AI assistance is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not provided. The document does not describe a standalone performance study. The device is intended to be used by radiation therapists and oncologists for patient positioning verification. The "standalone" performance in this context would likely refer to the image quality and accuracy of positioning measurements, but specific studies are not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided. As there is no described performance study or test set, the type of ground truth used is not mentioned.

8. The sample size for the training set

Not applicable/Not provided. This device is a hardware and software system for image acquisition and patient positioning, not a machine learning model that requires a "training set" in the conventional sense. The "Theraview Software" is mentioned, but its development process (e.g., if it uses machine learning and thus a training set) is not detailed.

9. How the ground truth for the training set was established

Not applicable/Not provided. (See point 8)

Summary of what is available and the overall approach:

The manufacturer, Acceletronics, Inc., is seeking 510(k) clearance for the RAD II Simulator & RAD II KV Imager by demonstrating substantial equivalence to predicate devices. This means they are asserting their device is as safe and effective as devices already on the market without needing to conduct extensive new clinical trials to prove efficacy from scratch.

Predicate Devices: Several predicate devices are identified, including Varian Medical Systems On-Board Imager, Varian Medical Systems Portal Vision, Elekta Synergy, Oldelft Simulux-HP, and Haynes Radiation Ltd., Inc. RAD II Simulator.
Description of Equivalence: The submission highlights that the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (IGRT) protocols, similar to predicate devices A-C. The RAD II Simulator is likened to predicate devices D&E as a "Radiation Therapy Simulator."
Technological Characteristics Comparison (Exhibit C-4): This table compares specific components and features (X-ray tube, generator, imager type, software) of the RAD II systems with the predicate devices, emphasizing their similarities. The key difference noted for the RAD II KV Imager is its advanced digital imaging compared to the older film-based RAD II Simulator, and some differences in imager/cassette mounting designs.
Intended Use Statement: The intended uses for both the KV Imager (patient position verification) and the Simulator (developing and verifying treatment protocols) are clearly stated and aligned with the intended uses of the predicate devices.

In essence, the "study" mentioned is the comparison of the device's technical specifications and intended use to legally marketed predicate devices, which is the basis for a 510(k) clearance. Clinical performance data or specific acceptance criteria with supporting studies are generally not required for substantial equivalence claims unless there are significant technological differences or new indications for use.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol on the left and the word "Acceletronics" on the right. The symbol is a combination of a circle with concentric rings and vertical bars. The word "Acceletronics" is written in a stylized font, and the letters have a textured appearance. The letters "SM" are written in a smaller font to the right of the word.

K101038

AUG 1 7 2010

510(k) Summarv May 10, 2010, revised 7/03/10

The following submission is provided following the format of 21CFR 807.92 for the RAD II Simulator & RAD II KV Imager.

1. Submitter: ACCELETRONICS, INC. 602 Gordon Drive Exton, PA. 19341 USA Contact: Stephen E. Havnes Phone: 510/867-5336 Fax: 510/522-2635 Email: shaynes@acceletronics.com
1. Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:

RAD II Simulator & RAD II KV Imager RAD II Simulator & RAD II KV Imager Therapy Attached Simulator/verification device System Simulator, Radiation Therapy 21CFR 892.5840 Class II Product Code: KPQ

3. Predicate Devices to claim substantial equivalence:

A) Varian Medical Systems On-Board Imager	K040192
B) Varian Medical Systems Portal Vision	K003636
C) Elekta Synergy	K032996
D) Oldelft Simulux-HP	K946128
E) Haynes Radiation Ltd., Inc. RAD II Simulator	K834281

Description of the device: The RAD II KV Imaging device is mounted directly to the 4. head of a Linear Accelerator or Cobalt Therapy device. This "Therapy Attached" application has been in use as the RAD II Simulator since 1983 (510K # K834281). With the addition of an FDA approved Digital Imager and Patient Positioning Software, the RAD II KV Imager operates as an "On Board Imaging Device" for Image Guided Radiation Therapy (I.G.R.T.) Protocols.
Substantial Equivalence = The RAD II is substantially equivalent in name to predicated devices A-E as a "Simulator" or "On Board Imager" device.
1. Intended Use Statement:
  A) The RAD II KV Imager device is used for verification of correct patient position in relation to the Radiation Therapy Machine Isocenter; and verification of the treatment fields in relation to anatomical and or fiducial landmarks prior to radiation therapy treatment.

Substantial Equivalence: The RAD II KV Imager is substantially equivalent in usage as an "On Board Imager" when compared to the predicated devices A-C.

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Image /page/1/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol on the left and the word "Acceletronics" on the right. The symbol is a combination of a target-like design and vertical bars. The word "Acceletronics" is written in a stylized font, and the letters are connected.

B) The RAD II Simulator device is intended for use in developing and verifying patient treatment positioning protocols for radiation therapy treatment of cancer.
Substantial Equivalence: The RAD II Simulator is substantially equivalent in usage as a "Radiation Therapy Simulator" when compared to the predicated devices D&E.
1. Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart on Exhibit C-4 provides a comparison of the technological characteristics and componentry to those of the predicate devices. The RAD II Simulator and the RAD II KV Imager are detailed in this chart Exhibit C-4 showing substantial equivalence of componentry to the predicate devices listed.
  A) The predicate devices use:

X-Ray Generator X-Ray Tube Collimator & Bearing Gantry Imaging Via X-ray Film Imaging Via Digital Imager Imaging Via Image intensifier Positioning Software Computer

RAD II Simulator and KV Imager Use:

X-Ray Generator X-ray Tube Collimator & Bearing Mounted to a Gantry Imaging Via X-ray Film Imaging Via Digital Imager lmaging via X-ray film Positioning Software Computer

. The RAD II Simulator & RAD II KV Imager are substantially equivalent to the predicate RAD II Simulator device in almost all of its predicate capabilities. The differences exist in the RAD II KV Imager which has no delineator, but has advanced digital imaging,
The RAD II Simulator & RAD II KV Imager are substantially equivalent to the . Oldelft Standalone Simulator in their ability to create relevant Patient positioning lmages for Radiation Therapy Treatment protocols, while using the Therapy gantry they are mounted to, and the Therapy couch, which is part of the Therapy System assembly.
. The RAD II KV Imager is substantially equivalent to the predicate Varian On-Board lmager as a Therapy attached diagnostic device using digital imaging and Patient positioning software for required adjustments and verification for Radiation Therapy Treatment Protocols.
The RAD II KV Imager is substantially equivalent to the predicate Portal Vision . Devices as a Therapy attached digital imaging Device using Digital Imaging and patient positioning software for required adjustments and verification for Radiation Therapy Treatment Protocols.

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Image /page/2/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol on the left, resembling a target or radar screen, followed by the word "Acceletronics" in a stylized font. The letters of the word have a textured or patterned fill, and there is a small "SM" symbol in the lower right corner of the word.

Exhibit C-4RAD II Make, Model &Operational Prd.	X-Ray TubeModel & Make	X-RayGeneratorModel & Make	Tube MountModel & Make	X-Ray FilmModel & Make	Film CassetteModel & Make	Imager Model& Make	Cassette &Imager MountModel & Make	PatientPositioningsoftware	Imager Comp.Model & Make	ApplicationComp. Model &Make	510KNumber
HRL RAD IIMODELPhantom-HF2003-Present	Phantom Hd.,Superior byDynarad & DelGlobal 50-100kVp	PhantomGeneratorDynarad & DellGlobal, 12.5mAfixed	VariableDesign by HRLfor Clinac &Cobalt	KodakT-Mat-H.	Kodak LannexRegular & Fast	None	VariableDesign by HRLfor Clinac &Cobalt	None	None	None	K834283
HRL RADII RadOnly MODEL 2001-HF 1994-1999	Rad-74, Eureka50-125kVp	Futurus 2001Generator byInnerscan 50-500mA	VariableDesign by HRLfor Clinac &Cobalt	KodakT-Mat-H	Kodak LannexRegular	None	VariableDesign by HRLfor Clinac &Cobalt	None	None	None	K834281
HRL RAD IIRad Only MODEL2001-HF 1999-Present	Rad-74, Varian50-125kVp	SHF-320Generator bySEDECAL25-300mA	VariableDesign by HRLfor Clinac &Cobalt	KodakT-Mat-H	Kodak LannexRegular	None	VariableDesign by HRLfor Clinac &Cobalt	None	None	None	K834281
SingleHeaded RADII KV ImagerMODEL 2001-HF2009-Present	Qty. 1Rad-60, Varian50-150kVp	(1) SHF-320Generator bySEDECAL25-300mA	HRL Shut Down in 2006, purchased bu Acceletronics in 2007. RAD II KV Imager product developed from 2008-2009			QTY.1NAOMI Imagerby RFSYSTEMSLAB	Fixed orRetractableArm Design byAcceletronicsforAccelerators	TheraviewSoftware byCablon	Mini Computerby Cablon	DELL PCLoaded withTheraviewsoftware	K101038
Dual HeadedRAD II KVImager MODEL2001-HF 2009-Present	Qty. 2Rad-60, Varian50-150kVp	(2) SHF-320Generator bySEDECAL25-300mA	RetractableDesign byAcceletronicsforAccelerators	None	None	QTY.2NAOMI Imagerby RFSYSTEMSLAB	RetractableArm Design byAcceletronicsforAccelerators	TheraviewSoftware byCablon	Mini Computerby Cablon	DELL PCLoaded withTheraviewsoftware	K101038
Varian O.B.I.2004-Present	Qty. 1Rad-60, Varian50-150kVp	(1) CPI Indico100 Generatorby CPI 25-300mA	RetractableHead Designby Varianmounts to	None	None	Varian 4030AmorphSiliconeImaging Panel	RetractableArm Design byVarian mountsto middle ofRetractablE	ProprietarySoftware	Unknown?	PC atTherapistConsole Area	K040192
Elekta SynergyImager 2003to present	Qty. 1 RotatingAnode Tube 50125kVp	(1) Generatormake/modelunknown	Retractable HeadDesign mounts tomid-gantry ofClinac	None	None	AmorphSiliconeImaging Panel	Arm Design byElekta mountsto middle ofRetractablE	ProprietarySoftware	Unknown?	PC atTherapistConsole Area	K032996
Varian PortalVision 2004-Present				None	None	Varian 4030AmorphSiliconeImaging Panel	RetractableArm Design byVarian mountsto Ctwt, Ass.	ProprietargSoftware	Unknown?	PC atTherapistConsole Area	K003636
Theraview				None	None	CCD CameraImaging Panel	Theraview Rot. ArmDarian mounts toGantry Chut. Arry.	ProprietarySoftware	Unknown?	PC atTherapistConsole Area	K960510
Oldelft Simulux-HP	Qty. 1 R/FRotatingAnode Tube 50150kVp	(1) R/FX-RayGenerator25-500mA	StandaloneGantrySimulates anAccelerator	None	None	Glass ImageIntensifier -Variable sizes	Variable imagerArm Design byOldelft mountsto lower Gantry	ProprietarySoftware	Unknown?	PC atTherapistConsole Area	K945128
RAD IISimulator	Qty. 1 FixedAnode Tube 50125kVp	(1) Generatormake by PortaRay/Dynarad	Typically fixedAdapter mountsto Head ofAccelerator	None	KodakLannex FastCassettes		VariableDesign by HRLfor Clinac &Cobalt				K834281

・

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling birds in flight or flowing lines, stacked vertically.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Stephen Haynes Project Design & Engineering Acceletronics Digital Imaging, LLC 602 Gordon Drive EXTON PA 19341

AUG 1 7 2010

Re: K101038

Trade/Device Name: Rad II KV Imager & RAD II Simulator Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulator system Regulatory Class: II Product Code: KPQ . Dated: July 29, 2010 Received: July 30, 2010

Dear Mr. Haynes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number

(800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device . Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Acceletronics. The logo consists of a stylized symbol to the left of the company name. The symbol is made up of concentric arcs intersected by vertical and horizontal lines, resembling a target or radar screen. The text "Acceletronics" is written in a stylized font to the right of the symbol, with the letters slightly slanted and connected.

K101038

Indications for Use Revised 7/03/10

510(k) Number (if known): K101038

Device Name: Rad II KV Imager & RAD II Simulator

Indications for use:

1. Both the RAD II KV Imager and RAD II Simulator are used in the field of Radiation Therapy as diagnostic imaging devices for patient positioning verification prior to radiation therapy treatments for cancer.
1. Both the RAD II KV Imager and RAD II Simulator are permanently mounted to the Therapy Head of Linear Accelerators and Cobalt Teletherapy devices.
1. The RAD II KV Imager is an "On Board Imager" intended for usage as a patient positioning verification device.
1. The RAD II KV Imager uses digital imaging to acquire its images, and positioning software to verify and/or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.
1. The RAD II Simulator is a "Therapy Attached" Simulator intended for developing and or verifying patient treatment protocols as prescribed by Radiation Oncologist.
1. The RAD II Simulator device uses standard x-ray film to acquire its images, which are reviewed by the Therapist and or Oncologist to either verify or adjust patient positioning prior to radiation therapy treatment via a Clinac as prescribed by a Radiation Oncologist.

Prescription Use YES AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OIVD

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K101038

Page 4.1

Acceletronics Digital Imaging, LLC. · 602 Gordon Drive · Exton, PA 19341 Toll Free 800-543-5144 · Service Dispatch 800-626-8704 · Fax 610-524-3304 · www.acceletronics.com

Regulation Number and Section

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.